PMID- 26927498
OWN - NLM
STAT- MEDLINE
DCOM- 20160815
LR  - 20220410
IS  - 2168-6114 (Electronic)
IS  - 2168-6106 (Linking)
VI  - 176
IP  - 4
DP  - 2016 Apr
TI  - Efficacy and Safety of Flibanserin for the Treatment of Hypoactive Sexual Desire 
      Disorder in Women: A Systematic Review and Meta-analysis.
PG  - 453-62
LID - 10.1001/jamainternmed.2015.8565 [doi]
AB  - IMPORTANCE: In August 2015, the US Food and Drug Administration (FDA) approved 
      flibanserin as a treatment for hypoactive sexual desire disorder (HSDD) in 
      premenopausal women, despite concern about suboptimal risk-benefit trade-offs. 
      OBJECTIVE: To conduct a systematic review and meta-analysis of randomized 
      clinical trials assessing efficacy and safety of flibanserin for the treatment of 
      HSDD in women. DATA SOURCES: Medical databases (among others, Embase, Medline, 
      Psycinfo) and trial registries were searched from inception to June 17, 2015. 
      Reference lists of retrieved studies were searched for additional publications. 
      STUDY SELECTION: Randomized clinical trials assessing treatment effects of 
      flibanserin in premenopausal and postmenopausal women were eligible. No age, 
      language, or date restrictions were applied. Abstract and full-text selection was 
      done by 2 independent reviewers. DATA EXTRACTION AND SYNTHESIS: Data were 
      extracted by one reviewer and checked by a second reviewer. Results were pooled 
      using 2 approaches depending on the blinding risk of bias. MAIN OUTCOMES AND 
      MEASURES: Primary efficacy outcomes included number of satisfying sexual events 
      (SSEs), eDiary sexual desire, and Female Sexual Function Index (FSFI) desire. 
      Safety outcomes included, among others, 4 common adverse events (AEs): dizziness, 
      somnolence, nausea, and fatigue. RESULTS: Five published and 3 unpublished 
      studies including 5914 women were included. Pooled mean differences for SSE 
      change from baseline were 0.49 (95% CI, 0.32-0.67) between 100-mg flibanserin and 
      placebo, 1.63 (95% CI, 0.45-2.82) for eDiary desire, and 0.27 (95% CI, 0.17-0.38) 
      for FSFI desire. The risk ratio for study discontinuation due to AEs was 2.19 
      (95% CI, 1.50-3.20). The risk ratio for dizziness was 4.00 (95% CI, 2.56-6.27) in 
      flibanserin vs placebo, 3.97 (95% CI, 3.01-5.24) for somnolence, 2.35 (95% CI, 
      1.85-2.98) for nausea, and 1.64 (95% CI, 1.27-2.13) for fatigue. Women's mean 
      global impression of improvement scores indicated minimal improvement to no 
      change. CONCLUSIONS AND RELEVANCE: Treatment with flibanserin, on average, 
      resulted in one-half additional SSE per month while statistically and clinically 
      significantly increasing the risk of dizziness, somnolence, nausea, and fatigue. 
      Overall, the quality of the evidence was graded as very low. Before flibanserin 
      can be recommended in guidelines and clinical practice, future studies should 
      include women from diverse populations, particularly women with comorbidities, 
      medication use, and surgical menopause.
FAU - Jaspers, Loes
AU  - Jaspers L
AD  - Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the 
      Netherlands.
FAU - Feys, Frederik
AU  - Feys F
AD  - Department of Family Medicine, Vrije Universiteit Brussel, Brussels, Belgium.
FAU - Bramer, Wichor M
AU  - Bramer WM
AD  - Medical Library, Erasmus University Medical Center, Rotterdam, the Netherlands.
FAU - Franco, Oscar H
AU  - Franco OH
AD  - Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the 
      Netherlands.
FAU - Leusink, Peter
AU  - Leusink P
AD  - Department of Sexology, Groene Hart Hospital, Gouda, the Netherlands.
FAU - Laan, Ellen T M
AU  - Laan ET
AD  - Department of Sexology and Psychosomatic Obstetrics and Gynecology, Academic 
      Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
PL  - United States
TA  - JAMA Intern Med
JT  - JAMA internal medicine
JID - 101589534
RN  - 0 (Benzimidazoles)
RN  - 37JK4STR6Z (flibanserin)
SB  - IM
CIN - JAMA Intern Med. 2016 Sep 1;176(9):1403-4. PMID: 27598749
CIN - JAMA Intern Med. 2016 Sep 1;176(9):1404-5. PMID: 27598750
MH  - Benzimidazoles/*therapeutic use
MH  - Dizziness/chemically induced
MH  - Fatigue/chemically induced
MH  - Female
MH  - Humans
MH  - Libido
MH  - Nausea/chemically induced
MH  - *Patient Satisfaction
MH  - *Premenopause
MH  - Sexual Dysfunctions, Psychological/*drug therapy
MH  - Treatment Outcome
EDAT- 2016/03/02 06:00
MHDA- 2016/08/16 06:00
CRDT- 2016/03/02 06:00
PHST- 2016/03/02 06:00 [entrez]
PHST- 2016/03/02 06:00 [pubmed]
PHST- 2016/08/16 06:00 [medline]
AID - 2497781 [pii]
AID - 10.1001/jamainternmed.2015.8565 [doi]
PST - ppublish
SO  - JAMA Intern Med. 2016 Apr;176(4):453-62. doi: 10.1001/jamainternmed.2015.8565.